Senior Quality Control Engineer
Katalyst Healthcares and Life Sciences
Roles & Responsibilities:
- Lead implementation and integration activities for GMP QC systems.
- Coordinate system configuration, data migration, deployment, and stakeholder engagement.
- Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence.
- Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
- Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.
- 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
- Experience managing system integrations, data migration, and cross-functional project delivery.
- Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.Strong stakeholder management, Agile/Scrum, and project coordination skills.Excellent communication and documentation capabilities
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Quality Control Engineer in Frankford, DE vacancy
- ...Senior Programmer AnalystThis full-time position is based in Millsboro, DE, requiring onsite presence. The role involves designing and implementing complex projects, mentoring junior team members, and collaborating with various departments. Candidates should have extensive...SeniorFull time
Mitchell Martin
Millsboro, DE4 days ago - ...and accounting professionals Ensure compliance with applicable accounting and tax requirements Help improve processes, systems and controls as the company grows Serve as a trusted financial resource to leadership What Success Looks Like Here Financial information is...Senior
Seaside Plumbing
Bishopville, MD5 days ago $88k - $100k
...Senior Programmer Analyst_Millsboro, DE_Full-Time(FTE)_Direct Hire Hi, Trust this finds you well! We've spotted your impressive profile and have an exciting opportunity tailored to your skills and passions. Position Title: Senior Programmer Analyst Job...SeniorFull timeRelocation package- ...TUI already deploying Parloa at scale. About the role: As a Senior Software Engineer, you will work on a marketplace of tools and integrations... ...business systems dramatically increases their value while controlling for security and risk. You haven't worked with our stack?...Senior
Senovo Capital Management GmbH
Berlin, MD2 days ago - ...into a global leader in sophisticated metropolitan living, renowned for its iconic designs, groundbreaking partnerships, and museum-quality art installations. Over 45 years, Related has built, rehabilitated, and managed over 110,000 units, earning its place as one of the...SeniorWork at officeFlexible hours
- ...OVERVIEWStarwood Hotels is seeking a detail-oriented, service-minded Senior Benefits Analyst to join our team. Reporting to the Executive... ...and recommend improvements to accuracy, efficiency, internal controls, and the team member experience.Develop standardized procedures...SeniorTemporary workLive inNight shift
- ...developing corrective action plans, act as a technical resource to address and resolve inquiries and problems regarding production, quality and work problems as appropriate. Compliance inspections- determine the nature of code violationsand actions to be taken,...SeniorLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Quality Control Engineer. Be the first to apply!
